Drug Therapy for Alcohol Dependence in Alaska Natives (Naltrexone/Sertraline)

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the ability of naltrexone (Revia) to reduce the risk of relapse in Alaska natives with alcohol dependence. The study will also examine whether a combination of naltrexone and sertraline (Zoloft) yields better abstinence rates than naltrexone used alone. Alaska Native individuals will be recruited into a 16 week outpatient study.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ethanol; Naltrexone; Sertraline

Criteria

Inclusion Criteria:

• Alaska Native having biological Alaska Native ancestry.

• Meets criteria for alcohol dependence.

• Prior to entering the study must be abstinent between 3 and 14 days and have a withdrawal assessment.

• Stable residence to ensure that subjects can be located during the study.

Exclusion Criteria:

• Currently meets criteria for abuse or dependence on substances other than alcohol or nicotine.

• Current use of disulfiram.

• Psychotic or otherwise severely psychiatrically disabled.

• Use of other psychotropic medications including antidepressants and anxiolytics.

• Medical conditions that would not permit the use of sertraline or naltrexone, such as a history of unstable or severe hepatic, cardiovascular, metabolic, endocrine, gastrointestinal or kidney disease.

• Hepatocellular disease or elevated bilirubin levels.

• Females who are pregnant, nursing, or not using a reliable method of birth control.

• Probation or parole requirements that might interfere with participation in the study.

• Involvement in alcohol treatment other than provided by the study or AA.

• Use of monoamine oxidase inhibitors in the past month.

• Current use of Type 1C antiarrhythmics propafenone and flecainide.